Phase 3
Completed N=354
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil
Vaccines, Pneumococcal Conjugate Vaccine
Source: ClinicalTrials.gov NCT00676091 ↗
Enrolled (actual)
354
Serious AEs
4.2%
Results posted
Oct 2010
Primary outcomePrimary: Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series — 100.0; 100.0; 96.8; 95.6 percentage of participants
Summary
The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series |
100.0; 100.0; 96.8; 95.6; 98.7; 100.0 | — |
| PRIMARY Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series |
35.9; 32.3; 70.1; 71.5; 93.5; 96.2 | — |
| SECONDARY Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose |
100.0; 100.0; 97.4; 98.7; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose |
50.7; 49.3; 91.4; 88.8; 99.3; 98.7 | — |
Eligibility Criteria
Inclusion criteria
- Healthy 1 month old infants
- Available for the duration of the study and reachable by telephone
- Able to complete two blood drawing procedures during the study
Exclusion criteria
- Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components
- Bleeding disorder, immune deficiency or significant chronic or congenital disease
- Previous receipt of blood products or immune globulin
Data sourced from ClinicalTrials.gov (NCT00676091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.